MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) EXPECT PULMONARY OLYMPUS 25GA; ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE

Model Number M00558250

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

This report pertains to one of two of the same device used during the same procedure.Manufacturer report # 3005099803-2016-03729 and 3005099803-2016-03730 for the other associated device information.It was reported to boston scientific corporation that two expect pulmonary olympus needles were used in the airway during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2016.According to the complainant, during the procedure the distal tip of the first needle was bent and the stylet was difficult to advance through the device.A second needle was used however, the distal tip was bent and the stylet was difficult to advance through the device.The procedure was completed with another expect pulmonary olympus.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

Visual evaluation of the returned device revealed that the working length of the needle and sheath was kinked at distal end of the handle.Additionally, the needle was bent at the distal end.Functional analysis showed that the device can be extended but with resistance due to the kink.Second functional analysis showed that the stylet could not be completely advanced due to the kink and bend found in the device.The reported complaint that the needle was bent was confirmed.Due to operational/anatomical factors encountered during the procedure; performance of the device was limited.Therefore, the most probable root cause classification for the reported failure is operational context.

Event Description

This report pertains to one of two of the same device used during the same procedure.Manufacturer report # 3005099803-2016-03729 and 3005099803-2016-03730 for the other associated device information.It was reported to boston scientific corporation that two expect pulmonary olympus needles were used in the airway during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2016.According to the complainant, during the procedure the distal tip of the first needle was bent and the stylet was difficult to advance through the device.A second needle was used however, the distal tip was bent and the stylet was difficult to advance through the device.The procedure was completed with another expect pulmonary olympus.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: EXPECT PULMONARY OLYMPUS 25GA
• Type of Device: ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6140031
• MDR Text Key: 61292780
• Report Number: 3005099803-2016-03730
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558250
• Device Catalogue Number: 5825
• Device Lot Number: M00558250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1